ADASUVE® (loxapine) inhalation powder, for oral inhalation use, can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services…
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INDICATIONS AND USAGE

ADASUVE® (loxapine) inhalation powder, for oral inhalation use, is
a typical antipsychotic indicated for the acute treatment of agitation associated
with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in
2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.

Limitations of Use: As part of the ADASUVE Risk Evaluation
and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE
must be administered only in an enrolled healthcare facility.

IMPORTANT SAFETY INFORMATION

ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services. Facilities must have a short-acting bronchodilator (eg, albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.

Because of the risk of bronchospasm, ADASUVE is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE
REMS.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs
are at an increased risk of death. ADASUVE is not approved for the treatment of
patients with dementia-related psychosis.

ADASUVE is contraindicated in patients with the following:

Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD),
or other lung disease associated with bronchospasm

Acute respiratory signs/symptoms (eg, wheezing)

Current use of medications to treat airways disease, such as asthma or COPD

History of bronchospasm following ADASUVE treatment

Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred
with oral loxapine and amoxapine

ADASUVE must be administered only by a healthcare professional

Prior to administration, all patients must be screened for a history of pulmonary
disease and examined (including chest auscultation) for respiratory abnormalities
(eg, wheezing)

Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation
using the single-use inhaler

After ADASUVE administration, patients must be monitored for signs and symptoms
of bronchospasm at least every 15 minutes for at least 1 hour

ADASUVE can cause sedation, which can mask the symptoms of bronchospasm

ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution
in patients with known cardiovascular disease, cerebrovascular disease, or conditions
that would predispose patients to hypotension. In the presence of severe hypotension
requiring vasopressor therapy, epinephrine should not be used

ADASUVE may increase the risk of falls, which could cause fractures or other injuries.
Patients taking antipsychotics with certain health conditions or those on long-term therapy
should be evaluated by their healthcare professional for the potential risk of falls

Use ADASUVE with caution in patients with a history of seizures or with conditions
that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures
have occurred in patients treated with oral loxapine, and can also occur in epileptic
patients

Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking,
and motor skills

The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants

Treatment with antipsychotic drugs caused an increased incidence of stroke and transient
ischemic attack in elderly patients with dementia-related psychosis; ADASUVE is
not approved for the treatment of patients with dementia-related psychosis

Use of ADASUVE may exacerbate glaucoma or cause urinary retention

The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical
studies in patients with agitation treated with ADASUVE were dysgeusia, sedation,
and throat irritation

Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester
of pregnancy are at risk of extrapyramidal and/or
withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus

Nursing mothers: Discontinue drug or nursing, taking into account the importance
of the drug to the mother

The safety and effectiveness of ADASUVE in pediatric patients have not been established

INDICATIONS AND USAGE

ADASUVE® (loxapine) inhalation powder, for oral inhalation use, is
a typical antipsychotic indicated for the acute treatment of agitation associated
with schizophrenia or bipolar I disorder in adults. Efficacy was demonstrated in
2 trials in acute agitation: one in schizophrenia and one in bipolar I disorder.

Limitations of Use: As part of the ADASUVE Risk Evaluation
and Mitigation Strategy (REMS) Program to mitigate the risk of bronchospasm, ADASUVE
must be administered only in an enrolled healthcare facility.

IMPORTANT SAFETY INFORMATION

ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer ADASUVE only in an enrolled healthcare facility that has immediate access on site to supplies and personnel trained to manage acute bronchospasm, and ready access to emergency response services. Facilities must have a short-acting bronchodilator (eg, albuterol), including a nebulizer and inhalation solution, for the immediate treatment of bronchospasm. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with ADASUVE.

Because of the risk of bronchospasm, ADASUVE is available only through a restricted
program under a Risk Evaluation and Mitigation Strategy (REMS) called the ADASUVE
REMS.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs
are at an increased risk of death. ADASUVE is not approved for the treatment of
patients with dementia-related psychosis.

ADASUVE is contraindicated in patients with the following:

Current diagnosis or history of asthma, chronic obstructive pulmonary disease (COPD),
or other lung disease associated with bronchospasm

Acute respiratory signs/symptoms (eg, wheezing)

Current use of medications to treat airways disease, such as asthma or COPD

History of bronchospasm following ADASUVE treatment

Known hypersensitivity to loxapine or amoxapine. Serious skin reactions have occurred
with oral loxapine and amoxapine

ADASUVE must be administered only by a healthcare professional

Prior to administration, all patients must be screened for a history of pulmonary
disease and examined (including chest auscultation) for respiratory abnormalities
(eg, wheezing)

Administer only a single 10 mg dose of ADASUVE within a 24-hour period by oral inhalation
using the single-use inhaler

After ADASUVE administration, patients must be monitored for signs and symptoms
of bronchospasm at least every 15 minutes for at least 1 hour

ADASUVE can cause sedation, which can mask the symptoms of bronchospasm

ADASUVE can cause hypotension, orthostatic hypotension, and syncope. Use with caution
in patients with known cardiovascular disease, cerebrovascular disease, or conditions
that would predispose patients to hypotension. In the presence of severe hypotension
requiring vasopressor therapy, epinephrine should not be used

ADASUVE may increase the risk of falls, which could cause fractures or other injuries.
Patients taking antipsychotics with certain health conditions or those on long-term therapy
should be evaluated by their healthcare professional for the potential risk of falls

Use ADASUVE with caution in patients with a history of seizures or with conditions
that lower the seizure threshold. ADASUVE lowers the seizure threshold. Seizures
have occurred in patients treated with oral loxapine, and can also occur in epileptic
patients

Use caution when driving or operating machinery. ADASUVE can impair judgment, thinking,
and motor skills

The potential for cognitive and motor impairment is increased when ADASUVE is administered
concurrently with other CNS depressants

Treatment with antipsychotic drugs caused an increased incidence of stroke and transient
ischemic attack in elderly patients with dementia-related psychosis; ADASUVE is
not approved for the treatment of patients with dementia-related psychosis

Use of ADASUVE may exacerbate glaucoma or cause urinary retention

The most common adverse reactions (incidence ≥2% and greater than placebo) in clinical
studies in patients with agitation treated with ADASUVE were dysgeusia, sedation,
and throat irritation

Pregnancy Category C. Neonates exposed to antipsychotic drugs during the third trimester
of pregnancy are at risk of extrapyramidal and/or
withdrawal symptoms after delivery. ADASUVE should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus

Nursing mothers: Discontinue drug or nursing, taking into account the importance
of the drug to the mother

The safety and effectiveness of ADASUVE in pediatric patients have not been established

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ADASUVE REMS PROGRAM

To administer ADASUVE® (loxapine)
inhalation powder, healthcare facilities
must enroll in the ADASUVE REMS Program

Because of the risk of bronchospasm, ADASUVE can only be administered in healthcare facilities that are enrolled in the ADASUVE
REMS Program.

For more information on the ADASUVE REMS Program,
please call 855-755-0492 or visit

By clicking the above link, you will leave ADASUVE.COM and be redirected to the
ADASUVE REMS Program site.